Dose titration of incobotulinumtoxinA for treatment of multifocal upper- and lower limb spasticity

Introduction/Background Effective treatment of disabling, multifocal upper- and/or lower limb spasticity may require botulinum neurotoxin doses higher than those indicated currently. TOWER ( NCT01603459 ) previously investigated the safety and efficacy of escalating incobotulinumtoxinA doses (400– ≤ 800U) in adults with upper- and lower limb spasticity due to stroke or other cerebral causes (Wissel. Neurology , 2017). Here, we report further data regarding the impact of escalating doses on multi-pattern treatment and muscle dosing. Material and method Treatment comprised three injection cycles (ICs) with escalating total doses on the same body side, each followed by 12–16 weeks’ observation: IC1, 400U into the upper limb and/or lower limb; IC2, 600U into the upper limb and/or lower limb; and IC3, 600–800U into the upper and lower limbs (maximum 600U per limb). At screening, investigators selected a target clinical pattern for treatment in all ICs. Other patterns were treated at the investigator's discretion. Results In total, 155 patients (mean [SD] age, 53.7 [13.1] years) were enrolled, with spasticity due to stroke (85.2%) or other cerebral causes (14.8%). The number of clinical patterns and muscles treated increased with escalating dose at each IC. In IC1, IC2 and IC3, respectively, 608, 743 and 811 clinical patterns and 46, 49 and 53 different muscles were treated in 155, 152 and 140 patients. The number of patients treated for the most frequently injected clinical patterns in the upper (flexed elbow) and lower limb (pes equinovarus), respectively, increased from 75.5% and 56.8% of patients in IC1 to 88.6% and 87.1% in IC3. Conclusion Escalating incobotulinumtoxinA doses enabled a more comprehensive multi-pattern treatment approach, with an increase of approximately 33% in clinical patterns and more muscles treated with the highest dose (600–800U) versus the initial dose (400U) in patients with upper- and lower limb spasticity.